Tag: radiotherapy

The growth in sales of a medical technology is dictated by a unique combination of a specific technology in a specific clinical application in a specific geographic market.

In the Smithers Apex report, “The Future of Tissue Ablation Products to 2020“, the markets for the different ablation technology types were assessed per application in each of the major world geographies. See the groupings, below:

Ablation Types and Clinical Applications:

Electrosurgical/radiofrequency

Cardiac

Surgical

Microwave

Oncologic

Urologic

Laser

Aesthetic

Ophthalmic

Surgical

External Beam Radiation Therapy (EBRT)

LINAC Systems

Cobalt-60

Cryoablation

Cardiac & Vascular

Oncologic Surgery

GYN Surgery

Dermal/Cutaneous Surgical

Ultrasound

Ophthalmic (Cataract) Surgical

Multipurpose Surgical

Urologic Surgical

Multipurpose High Intensity Focused Ultrasound (HIFU)

Geographic Areas:

United States & Other Americas

Largest Western & European States

Major Asian States

Rest of World

The Smithers Apex report contains the detailed assessment of ablation technology sales in each combination of technology, geography and clinical application. Below is illustrated graphically, sorted by compound annual growth rate in sales, each of the combinations.

Growth of Ablation Technologies by Clinical Application and Geography, 2014-2020

The “traditional” types of tissue ablation — electrosurgery and radiation therapy — are losing relative share as new modalities are able to penetrate caseload of other modalities, or even tap previously untreated patients and increase the aggregate caseload. In particular, radiofrequency and cryotherapy will demonstrate the highest growth over the 2011 to 2019 period.

The global market for medical devices is $200 billion opportunity and at least 13% of this market involves products that provide the controlled application of energy to tissue. The segment is dominated by high technology products ranging from devices that can heat and cool tissue over a 600° C temperature range of -200° C to +400° C to those that can vibrate at fifty five thousand cycles per second to denature tissue. While a significant share of the energy-based therapies market is for elective procedures such as refractive eye surgery and cosmetic hair removal, treatments for chronic diseases make up the vast majority of the applications of these technologies.

Underlying the growth of this market will be changes in demographics. The baby boomer generation–those born between 1946 and 1964–represents about one-third of the population in economically-developed countries. Many of these ageing citizens have both the economic means and the demand for therapies that can extend their active lives and delay the visible signs of aging.

Pushing the growth of energy therapies beyond basic changes in demographics are the unique benefits that they offer. They are typically less invasive than traditional surgery and are generally employed without the need for an implant. The therapies can be precisely metered and can be repeated. Emerging energy modalities have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve.

Ablation technologies of different types have in common their ability to produce a therapeutic effect on human tissue. Beyond this common ground, however, there are stark differences in the modalities. Consequently, ablation technologies have variable penetration of clinical applications, with use of specific modalities for specific clinical applications driven by factors such as the tissue effect produced, likelihood of collateral tissue damage, the designs of manufacturers’ specific systems in meeting clinicians needs, cost, and other considerations.

Cancer treatment is a good example, with a few modalities having significant shares of their worldwide ablation revenuesin cancer, while other modalities are little used in these areas.

Energy-based technologies and treatments exist for virtually all clinical specialties. Given the ability of these technologies, particularly ablation technologies, to very precisely destroy tissue, they have been strongly developed for cancer applications and much success has already been achieved in producing treatments that have low risk, short recovery times and good long term outcomes. Cost is non insignificant for these technologies, but thus far their clinical benefits have generally supported strong reimbursement.

Energy-based cancer treatment regimens consist of external beam radiation therapy, brachytherapy and a number of newer applications of energy therapies that ablate cancerous tissue. Prostate cancer for example, the most prevalent cancer among U.S. men, can now be treated with a range of energy based therapies that effectively supplement chemotherapy and other targeted therapeutics.

The range of energy modalities used for ablation in cancer include the following:

brachytherapy

cryotherapy

microwave ablation

radiation therapy

radiofrequency (RF) ablation

stereotactic surgery

laser ablation

photodynamic therapy

ultrasonic ablation

As well, there are combinations of the above, and several of these (e.g., radiation therapy) have many variations in the way they can be delivered (note, for example, the overlap between brachytherapy, radiation therapy and stereotactic surgery).

Manufacturers of ablation and other energy-base therapeutics are both witnessing and driving a steady evolution of multiple technologies with potential to produce therapeutic (or, in some cases, simply cosmetic) tissue effects, with different energy types competing head-on for caseload. These innovators have continued to improve their understanding of the nature of each energy type’s impact on the target tissue(s) and have optimized the delivery to improve outcome, improve ease of use and minimize adverse collateral tissue effects or other complications.

To illustrate the breadth of applications for energy-based technologies, see the excerpt below from the table of contents to the MedMarket Diligencereport #A125, "Ablation Technologies Worldwide Market, 2008-2017: Products, Technologies, Markets, Companies and Opportunities."

SECTION 1:ENERGY-BASED THERAPIES BY DISEASE STATE AND TECHNOLOGY

1.1Cancer

1.1.1Brachytherapy

1.1.2Cryotherapy

1.1.3Microwave Ablation

1.1.4Radiation Therapy

1.1.5Radiofrequency Ablation

1.1.6Stereotactic Surgery

1.1.7Laser Ablation

1.1.8Photodynamic Therapy

1.1.9Ultrasonic Ablation

1.2Cardiovascular Disease

1.2.1Angina Pectoris

1.2.2Atrial arrhythmias

1.2.2.1Cryoablation

1.2.2.2Electrical Cardioversion

1.2.2.3Microwave Ablation

1.2.2.4RF Ablation

1.2.2.5Temperature Controlled

1.2.2.6Fluid Cooled

1.2.3Bradycardia

1.2.4Critical Ischemia

1.2.5Vascular Occlusive Disease

1.2.6Ventricular Arrhythmias

1.2.6.1About ICD, CRT and CRT-D

1.2.7Wolf-Parkinson-White Disease

1.3Elective Surgery

1.3.1Cosmetic Surgery

1.3.1.1Laser Hair Removal

1.3.1.2Port Wine Stains

1.3.1.3Psoriasis

1.3.1.4Varicose Veins

1.4Ophthalmic Surgery

1.4.1Capsulotomy Surgery

1.4.2Laser In-Situ Keratomileusis (LASIK)

1.4.3Laser Epithelial Keratomileusis (LASEK)

1.5General Surgery

1.5.1Fecal Incontinence

1.5.2Gastroesophageal Reflux Disease (GERD)

1.6Gynecological Applications

1.6.1Hysterectomy

1.6.2Menorrhagia

1.6.3Fibroids

1.6.4Bladder Neck Suspension

1.7Urological Applications

1.7.1Urinary Tract Stones

1.7.2Benign Prostatic Hypertrophy

1.7.2.1TUMT

1.7.2.2TUNA

1.7.2.3Photoselective Vaporisation of the prostate (PVP)

1.7.2.4HoLAP

1.7.2.5CoreTherm

1.7.2.6TMX 3000

1.7.2.7Prolieve

1.7.2.8Prostiva RF Therapy

1.7.2.9Water-Induced Thermotherapy

1.8Tonsillectomy

1.9Orthopedic Applications

1.9.1Capsular Shrinkage

1.9.2Carpal Tunnel Syndrome

1.9.3Chondroplasty

1.9.4Debridement

1.9.5Epicondylitis and Tendinitis

1.9.6Inflammatory Conditions

1.9.6.1Nucleoplasty

See the report’s complete description, table of contents, and list of exhibits here.

The world market for energy-based devices was well in excess of $25 billion in 2008. This represents almost 14% of the total medical device market; however, the share varies from country to country, since ablation therapy is high-technology and fairly high-cost; in poorer economies low-cost medical products such as syringes and consumables account for a relatively higher share of the medical market.

Analyses of the medical market by product category typically divide it into a small number of broad product classes such as electromedical equipment; syringes, needles and catheters; medical consumables; etc. The products included in "energy-based therapies" are divided among several of these categories.

Energy-based devices are of nine main categories, and the market share by category.

Worldwide Ablation and Other Energy-based Device Market by Product Category

Ultrasonic energy offers superior control of energy output. 3D control and directionality of the energy delivered provides the ability to treat a prescribed target volume and shape which is critical for tumor ablation as increased energy penetration into the target tissue enables the treatment of larger tumor volumes and reduces treatment times. Peripheral and coronary vascular occlusive conditions that afflict tens of millions of people worldwide are now being treated with technologies that enable the delivery of ultrasonic energy over the active length of a small diameter guidewire-like device in an occluded blood vessel. The popularity of ultrasonic surgical systems is being driven by their inherent advantages. These systems control bleeding by coaptive coagulation at low temperatures ranging from 50ºC to 100ºC. Coagulation occurs by means of protein denaturation as opposed to thermal welding and the absence of smoke improves the visual field.

Cryogenic energy or the extreme absence of heat is very attractive as it is highly containable and thus localized. Cryoablation can be safely employed adjacent to delicate tissue and structures such as certain vasculature. Cryoablation may eliminate many of the problems seen in treating complex arrhythmias such as pulmonary vein stenosis. Cooling freezes tissue and does not seem to cause extracellular matrix changes or damage to the endocardium, which may lower clot-related complications. Thanks largely to advances in ultrasound, which allows physicians to target diseased tissue with pinpoint accuracy, and temperature control, which allows physicians to destroy the diseased tissue without harming the surrounding healthy tissue, cryoablation has become the fastest growing minimally invasive option for prostate cancer patients.

Microwave energy offers the inherent advantage of accommodating parallel delivery points. An increased treatment area can be treated with microwave energy very efficiently. Microwave probes are ideally suited for a full spectrum of cardiac ablation procedure from simple pulmonary vein isolation in paroxysmal AF to a full Maze for permanent AF. Energy delivery times are short, on the order of 25 to 60 seconds, and the unidirectionality of the microwave ensures the protection of surrounding tissues during epicardial application–a significant requirement for beating-heart application. Microwave energy is also being used as a transurethral therapy to treat BPH.

Light energy is being harnessed and focused for a variety of therapeutic applications. CO2 lasers are being used to revascularize injured myocardial tissue while excimer lasers are being adapted to atherectomy catheters that can clear thrombosis and reperfuse vessels. Over 2 million individuals seek the therapeutic benefits of laser vision correction each year; low level “cold” lasers are being employed to treat chronic pain relief for debilitating conditions like carpal tunnel syndrome–a leading cause of lost workdays. Intense pulsed light (IPL) that affects subtle changes in collagen is being used to treat vascular and pigmentation irregularities.

Hydromechanical energy systems that jet streams of saline only five one-thousandths of an inch in diameter — about the thickness of a human hair–can precisely dissect tissue, sparing vessels and nerves, and are being employed for hepatic resection and nerve-sparing retropubic radical prostatectomy. This modality does not cause thermal damage to tissue and can sculpt, ablate and cauterize bleeders.

Radiation energy using focused arrays of intersecting beams of gamma radiation is being used to treat lesions within the brain. Radiosurgery devices that can ablate otherwise untreatable tumors and malformations when directed by computers are finding otherwise untreatable lesions.

Thermal energy is employed successfully to treat menorrhagia due to benign causes in premenopausal women. When tissue is heated above 46°C, cellular protein denatures and the cell dies. Thermal uterine balloon therapy offers a less-invasive option that allows women to preserve their uterus. Thermal therapy is also being employed for breast and prostate cancer. Implants made of ferromagnetic material that can be “turned-on” when placed within an electromagnetic field and heated in situ offer a high degree of specificity with respect to the treated tissue area.

Electrical energy delivered by small implants can deliver a life saving jolt of electricity to shock a patient’s heart back to normal when rhythmic disturbances of the lower heart chambers that can cause sudden cardiac death are detected. Similar devices deliver electrical energy to speed up a heart beating too slowly. Image-guided radiofrequency ablation which uses heat to destroy diseased tissue can preserve kidney function and avoid kidney dialysis for patients with solid renal tumors who are not surgical candidates.

Radiofrequency energy is gaining widespread use in the field of sports medicine surgery for the thermal modification of soft tissue structures within the joint. The use of radiofrequency energy for thermal chondroplasty has gained tremendous popularity because of the quality of the therapy. Radiofrequency surgical systems have the inherent ability to seal large vessels as a result of the tremendous temperatures the energy can generate.

The global market for medical devices is currently a $185 billion opportunity and at least 13% of this market involves products that provide the controlled application of energy to tissue. The segment is dominated by high technology products ranging from devices that can heat and cool tissue over a 600° C temperature range of -200° C to +400° C to those that can vibrate at fifty five thousand cycles per second to denature tissue. While a significant share of the energy-based therapies market is for elective procedures such as refractive eye surgery and cosmetic hair removal, treatments for chronic diseases make up the vast majority of the applications of these technologies.

Underlying the growth of this market will be changes in demographics. The baby boomer generation–those born between 1946 and 1964–represents about one-third of the population in economically-developed countries. Many of these ageing citizens have both the economic means and the demand for therapies that can extend their active lives and delay the visible signs of aging.

Pushing the growth of energy therapies beyond basic changes in demographics are the unique benefits that they offer. They are typically less invasive than traditional surgery and are generally employed without the need for an implant. The therapies can be precisely metered and can be repeated. Emerging energy modalities have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve.

Ultrasonic energy offers superior control of energy output. 3D control and directionality of the energy delivered provides the ability to treat a prescribed target volume and shape which is critical for tumor ablation as increased energy penetration into the target tissue enables the treatment of larger tumor volumes and reduces treatment times. Peripheral and coronary vascular occlusive conditions that afflict tens of millions of people worldwide are now being treated with technologies that enable the delivery of ultrasonic energy over the active length of a small diameter guidewire-like device in an occluded blood vessel. The popularity of ultrasonic surgical systems is being driven by their inherent advantages. These systems control bleeding by coaptive coagulation at low temperatures ranging from 50ºC to 100ºC. Coagulation occurs by means of protein denaturation as opposed to thermal welding and the absence of smoke improves the visual field.

Cryogenic energy or the extreme absence of heat is very attractive as it is highly containable and thus localized. Cryoablation can be safely employed adjacent to delicate tissue and structures such as certain vasculature. Cryoablation may eliminate many of the problems seen in treating complex arrhythmias such as pulmonary vein stenosis. Cooling freezes tissue and does not seem to cause extracellular matrix changes or damage to the endocardium, which may lower clot-related complications. Thanks largely to advances in ultrasound, which allows physicians to target diseased tissue with pinpoint accuracy, and temperature control, which allows physicians to destroy the diseased tissue without harming the surrounding healthy tissue, cryoablation has become the fastest growing minimally invasive option for prostate cancer patients.

Microwave energy offers the inherent advantage of accommodating parallel delivery points. An increased treatment area can be treated with microwave energy very efficiently. Microwave probes are ideally suited for a full spectrum of cardiac ablation procedure from simple pulmonary vein isolation in paroxysmal AF to a full Maze for permanent AF. Energy delivery times are short, on the order of 25 to 60 seconds, and the unidirectionality of the microwave ensures the protection of surrounding tissues during epicardial application–a significant requirement for beating-heart application. Microwave energy is also being used as a transurethral therapy to treat BPH.

Light energy is being harnessed and focused for a variety of therapeutic applications. CO2 lasers are being used to revascularize injured myocardial tissue while excimer lasers are being adapted to atherectomy catheters that can clear thrombosis and reperfuse vessels. Over 2 million individuals seek the therapeutic benefits of laser vision correction each year; low level “cold” lasers are being employed to treat chronic pain relief for debilitating conditions like carpal tunnel syndrome–a leading cause of lost workdays. Intense pulsed light (IPL) that affects subtle changes in collagen is being used to treat vascular and pigmentation irregularities.

Hydromechanical energy systems that jet streams of saline only five one-thousandths of an inch in diameter — about the thickness of a human hair–can precisely dissect tissue, sparing vessels and nerves, and are being employed for hepatic resection and nerve-sparing retropubic radical prostatectomy. This modality does not cause thermal damage to tissue and can sculpt, ablate and cauterize bleeders.

Radiation energy using focused arrays of intersecting beams of gamma radiation is being used to treat lesions within the brain. Radiosurgery devices that can ablate otherwise untreatable tumors and malformations when directed by computers are finding otherwise untreatable lesions.

Thermal energy is employed successfully to treat menorrhagia due to benign causes in premenopausal women. When tissue is heated above 46°C, cellular protein denatures and the cell dies. Thermal uterine balloon therapy offers a less-invasive option that allows women to preserve their uterus. Thermal therapy is also being employed for breast and prostate cancer. Implants made of ferromagnetic material that can be “turned-on” when placed within an electromagnetic field and heated in situ offer a high degree of specificity with respect to the treated tissue area.

Electrical energy delivered by small implants can deliver a life saving jolt of electricity to shock a patient’s heart back to normal when rhythmic disturbances of the lower heart chambers that can cause sudden cardiac death are detected. Similar devices deliver electrical energy to speed up a heart beating too slowly. Image-guided radiofrequency ablation which uses heat to destroy diseased tissue can preserve kidney function and avoid kidney dialysis for patients with solid renal tumors who are not surgical candidates.

Radiofrequency energy is gaining widespread use in the field of sports medicine surgery for the thermal modification of soft tissue structures within the joint. The use of radiofrequency energy for thermal chondroplasty has gained tremendous popularity because of the quality of the therapy. Radiofrequency surgical systems have the inherent ability to seal large vessels as a result of the tremendous temperatures the energy can generate.

Given the varying clinical utilities of the different energy modalities and the correspondingly different current and potential caseload, the growth in the market for ablation technologies varies by modality, as shown below.

The medical markets inthe Asia/Pacific region show enormous variations in size, due to differences in healthcare expenditure as well as the obvious differing population sizes. Although China and India have vastly greater populations than other countries in the region, it is the Japanese ablation market that takes the largest share of the global market, with an estimated 6.2%. This country’s medical market has been showing a modest (3%) annual growth after a period of stagnation. However, in terms of absolute growth rate for sals of ablation technology products, India is the leader, edging out even China.

The report describes alternative energy-based technologies and the nature of their effect on soft tissue, the underlying basis of the technology, the requisite systems for their use (including capital equipment, devices and disposables), and their strengths and weaknesses for specific clinical applications. The report details current and anticipated target applications and assesses the current and forecast caseload for each energy-based therapeutic considering competition from any and all alternative energy-based or other therapeutics, with current and worldwide market forecasts (2008-2017) segmented by technology type and specific clinical segment. The report provides segmentation of the worldwide ablation market by both ablation technology and region/country: Americas (USA, Canada, Mexico, Brazil), Europe (Germany, United Kingdom, France, Italy, Spain, BeNeLux), Asia/Pacific (Japan, China, India, Australia) and Rest of World. The report details the current and emerging products, technologies and markets for each energy-based therapy. The report profiles over 60 key companies in this industry detailing their current products, current market position and products under development.